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FDA-VDM

STATEMENT OF AUTHORITY
AND
CONFIDENTIALITY COMMITMENT
FROM
THE UNITED STATES FOOD AND DRUG ADMINISTRATION
NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED
BY
THE UNITED KINGDOM VETERINARY MEDICINES DIRECTORATE

The purpose of this agreement is to strengthen communication, enhance international co-operation for the protection of public health, safety, animal health and welfare, and the environment, and to facilitate the sharing of information between the parties, with a view to assisting each party to improve its regulatory performance.

The United Kingdom Veterinary Medicines Directorate (VMD) is authorized to disclose non-public information to the United States Food and Drug Administration (FDA) regarding VMD-regulated products as part of cooperative law enforcement or cooperative regulatory activities.

FDA understands that some of the information it receives from the VMD may include non-public information exempt from public disclosure under the laws and regulations of the United Kingdom, such as confidential commercial information; trade secret information; personal privacy information; law enforcement information; or internal, pre-decisional information. FDA understands that this non-public information is shared in confidence and that the VMD considers it critical that FDA maintain the confidentiality of the information. Public disclosure of this information by FDA could seriously jeopardize any further scientific and regulatory interactions between VMD and FDA. The VMD will advise FDA of the non-public status of the information at the time that the information is shared.

Therefore, FDA certifies that:

FDA has the authority to protect from public disclosure such non-public information provided to FDA in confidence by the VMD;

FDA will not publicly disclose such VMD-provided non-public information without the written authorization of the owner of the information, the written authorization from the individual who is the subject of the personal privacy information, or a written statement from the VMD that the information no longer has non-public status;

any non-public information received from the VMD will be kept confidential and not released to any person other than members, agents or employees of FDA who need to know the information for work purposes and who have a legally enforceable obligation, such as, but not limited to an employment contract, an agency agreement, confidentiality agreement or other document that permits those persons to use the information for the purposes of this agreement and requires them to protect the confidentiality of the information in accordance with the laws of the United States of America;

FDA will inform the VMD promptly of any effort made by judicial or legislative mandate to obtain VMD-provided non-public information from FDA. If such judicial or legislative mandate orders disclosure of VMD-provided non-public information, FDA will take all appropriate legal measures in an effort to ensure that the information will be disclosed in a manner that protects the information from public disclosure; and 5. FDA will promptly inform the VMD of any changes to United States of Americas’ laws, or to any relevant policies or procedures, that would affect FDA’s ability to honor the commitments in this document.